PAR — Test, Volatile Organic Compounds Breath Analysis Class f
FDA product code PAR covers "Test, Volatile Organic Compounds Breath Analysis", a Class f medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PAR
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
Definition
Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.